efficacy and safety of bevacizumab/temsirolimus combination to treat advanced renal cell carcinoma

Conditions: Kidney Cancer

Summary: the purpose of this study is to determine whether the combination of bevacizumab/temsirolimus is effective in patients with advanced renal carcinoma progressing after anti-vegf treatment


Eligibility criteria:
inclusion criteria: * adult patients (18th year of age completed) * signed and dated written informed consent form prior to any procedures related to this protocol. * histologically confirmed advanced clear cell renal cancer. * measurable disease. * failure of first line anti-vegf treatment. * performance status 0-2, according to eastern cooperative oncology group (ecog) . * satisfactory hematological parameters: * white blood cell count \> 4000 mm3. * platelet count 100000/mm3. * neutrophil blood cell count \> 1200/ mm3 . * hemoglobin \> 9,0 g/dl (can be achieved with red blood cell transfusion). * satisfactory biochemical parameters: * serum creatinine \< 2 x upper limit of normal(uln) * aspartate aminotransferase (ast)\<2,5 x uln * alanine transaminase (alt)\< 2,5 x uln. * bilirubin \<2 x uln * (for female patients) absence of pregnancy (negative pregnancy test for women of reproductive age before enrollment). * (for female patients) non-lactating women. * use of efficient contraceptive measures (women and men) to prevent possible pregnancy of female patient or female partner of a male patient during treatment and until 6 months after the end of treatment. exclusion criteria: * prior treatment with mtor inhibitor. * major surgery (including open biopsy) or insufficient recovery or existence of major trauma within 4 weeks before enrollment. * uncontrolled hypertension. * active infection requiring systemic treatment within 4 weeks prior to enrollment. * minor surgery (for instance, catheter placement) within 2 days before enrollment. * scheduled major surgery within the treatment period. * medical history in the last 6 months prior to enrollment of significant cardiovascular disease, diabetes, cardiac infarction, unstable angina, uncontrolled arrhythmia or significant heart failure. * indications of uncontrolled metastases or disease progression in cns lesions (the suspicion of uncontrolled metastases or disease progression should be eliminated by imaging techniques within 14 days prior to enrollment). * medical history in the last 5 years prior to enrollment of any other malignancies (excluding the basal or squamous skin cell carcinoma or in situ carcinoma of the cervix). * history of non-healing wound including active gastric ulcer. * history of fistula in the last 6 months prior to enrollment. * history of gastrointestinal perforations. * patient incapacity (for psychiatric or social reasons) to conform with the protocol. * history of hemorrhagic predisposition. * history of hypersensitivity to the medications under investigation. * significant proteinurea. * prior immunotherapy within 4 weeks prior to enrollment. * prior radiation treatment within 2 weeks prior to enrollment. * concomitant medication with inducers or strong inhibitors of the coenzyme cyp3a4 (see appendix 5 for an indicative list of active compounds). * concurrent participation in other interventional clinical trials with investigational medicinal products. * history of chronic interstitial lung disease.